The present invention relates to a tracking system for ionizing radiation sterilized bags, filters, valves, tubing, medical devices and other disposables or non-disposables utilized in various fields, such as chemical, pharmaceutical, biological or other controlled manufacturing processes and/or storage, as well as for packaging and shipping of comestible products.
Many manufacturing and storage processes in the chemical, medical, pharmaceutical and biological fields utilize batch processes with various disposables or single use items for holding and transferring product in various stages, and include, for example, polymeric pouches or bags, tubing, valves, etc. Biobags or biotech drug processing bags, disposable bags or single use systems are generally made of polymeric sheet material which is manufactured into large or small bags that hold batches of pharmaceuticals or other materials during and/or after the manufacturing process. These bags and disposables must generally be sterilized, for example using ionizing radiation such as gamma radiation prior to use. Such bags are often used to make, store and/or distribute a single batch of drugs, and/or to store a batch of drugs or other material until it is ready to be dispensed into vials or bottles for distribution or further storage, or may be dispensed directly into further manufacturing and processing equipment. For example, such bags can be placed into and act as a liner for a stainless steel vat in a bio reactor. Generally, it is necessary not only to be able to track the information regarding the bag or disposable up until the time that it is discarded, but also its contents and the various steps or processes that have been carried out.
In the medical field, disposables are also used that are gamma radiation sterilized by the manufacturer, prior to being sent to a doctor or hospital for use in patient care. This can be done for individual items or in lots. These medical disposables are also tracked to ensure safety. Further, additional medical items, such as implants, also require gamma radiation sterilization and similar tracking requirements.
In the field of comestible products, including fruits and vegetables that are harvested, it would be desirable in many instances to track not only products, but whether or not the packaging with or without the products therein have been sterilized.
Systems are known for permanently associating and identifying indicia with such bags or disposables, such as bar codes. This is typically done in order to provide positive identification of the bag and/or disposable, or the associated product. Such indicia may be visually readable by a user or machine-readable, such as a bar code. This type of identification has been done in accordance with specific industry requirements, where it is often required to specifically identify the product and/or steps being tracked. However, such bar code systems do not allow any additional data to become associated and or carried with the item. Additionally, many users still use manual tracking of certificates of compliance, certifications of analysis, certifications of ionizing radiation exposure, dosimetry records as well as various other data that may become associated with a bag or disposable item and/or its contents during further manufacturing and/or processing
RF ID tags are known to allow information to be written to a specific tag associated with an item. Generally, the heart of an RF ID system is an information-carrying tag which functions in response to a coded RF signal received from a mobile reader or base station. The tag reflects the incident RF carrier back to the RF ID tag reader or base station and the information transferred as the reflected signal is modulated by the tag according to its programmed information protocol. RF ID tags may be active, in which a power source is provided, or passive, in which the energy for the reflected signal is derived from the RF signal from the base station or RF ID tag reader used to interrogate the tag. The RF ID tags can be programmed or encoded with specific information, such as an individual identification numbers for a product, such as serial numbers, and/or additional product information, depending upon the complexity of the RF ID tag. Read/write RF ID tags are also known which can be used to receive and store additional or updated data.
While RF ID tags have been known and have been adapted to various uses, such as inventory control and theft protection of items, they have been unsuitable for such bio bag or disposable items that require gamma radiated for sterilization due to the negative effect on the RF ID tag and the loss of associated data stored therein.
Accordingly, it would be desirable to provide a better system to track predetermined events with respect to items, such as those noted above, that are sterilized by ionizing radiation. It would also be desirable to be able to use the identification to obtain data, specifications and certifications as required from a manufacturer. It would also be desirable to provide an easier and more efficient system for tracking such items for various reasons, such as inventory control, active or useful life, shelf life of contents, etc.